After notifying the Medical Devices Rules 2017, which will come into
force in the country from January 1, 2018, the Union health ministry has
now issued the draft list of medical devices and in vitro diagnostics
along with their risk-based classifications.
As per the Medical
Devices Rules 2017, medical devices other than in vitro diagnostic
medical devices will be classified on the basis of parameters specified
in part I of the first schedule, namely low risk as Class A; low to
moderate risk as Class B; moderate to high risk as Class C; and high
risk as Class D. In vitro diagnostic medical devices will be classified
on the basis of parameters specified in part II of the First Schedule,
namely low risk as Class A; low to moderate risk as Class B; moderate to
high risk as Class C; and high risk as Class D.
The devices
intended for internal or external use in the diagnosis, treatment,
mitigation or prevention of disease or disorder in human beings or
animals, as may be specified from time to time by the Central government
by notification in official Gazette, after consultation with the Drugs
Technical Advisory Board, fall under the definition of drug. The list
of 15 devices notified so far in the country include disposable
hypodermic syringes; disposable hypodermic needles; disposable perfusion
sets; in vitro diagnostic devices for HIV, Hbsag and HCV; cardiac
stents; drug eluting stents; catheters; intra ocular lenses; I.V.
cannulae; bone cements; heart valves; scalp vein set; orthopedic
implants; internal prosthetic replacements; and ablation device.
The
new Medical Devices Rules will be applicable to substances used for in
vitro diagnosis and surgical dressings, surgical bandages, surgical
staples, surgical sutures, ligatures, blood and blood component
collection bag with or without anticoagulant covered under sub-clause
(i); substances including mechanical contraceptives (condoms,
intrauterine devices, tubal rings), disinfectants and insecticides
notified under sub-clause (ii); and devices notified from time to time
under sub-clause (iv), of clause (b) of section 3 of the Drugs and
Cosmetics Act, 1940 (23 of 1940).
As per the draft list issued by
the ministry, Radiofrequency Ablation Device, Percutaneous Conduction
Tissue Ablation, Suction Ablation Catheter System, Fiberoptic Oximeter
Catheter, Cardiac Catherization Kit, Balloon for Cerebrovascular
Occlusion, Intra-Aortic System Balloon and Control, Keratoprosthesis,
Detachable coils, Bone heterograft, Vena cava clip, Implantable Infusion
pump, Glenoid fossa prosthesis, Vascular clip, Vascular embolization
device, Intervertebral body fusion device, Haemo-Dialyzer System,
Implantable cardiac pacemaker including accessories, Drug eluting stent,
Vascular graft/occluders/Cardiac Patches and Implanted
intracerebral/subcortical stimulator for pain relief, to name only a
few, have been listed in the high risk Class D category.
A-V
Shunt or Fistula Adapter, Enternal infusion Pump,
Transcervical(Aminosco pe) Endoscope and accessories, Forceps,
endoscopic, Anastomotic Microvascular Device, Angiographic Guide Wire
and Accessories, Vessel Dialator for percutaneous Catheterization,
Angioscope, Aspiration Needle and Syringe, Tracheobronchial Suction
Catheter, Cervical Drain, Rectal Balloon, Biliary Stone Retrieval
Basket, Contact Lens Bifola and Daily, Blood Administration kits,
Biopsy Kit, Tracheostomy Tube/Tracheal Tube, Irrigating Syringes,
Intravenous Cannula, Vial Adapter, Suprapubic, nondisposable Cannula and
Trocar, Aortic Cannula, Arterial Cannula, Coronary Artery Cannula,
Arthroscopy Drainage Cannula, Lacrimal, Hemodialysis Cannula, Cannula
Injection, Uterine Insufflation Cannula, Continuous Positive Airway
Pressure Nasal Oxygen Cannula, Salpngography Catheter, etc have beenl
isted in the Class B category.
Likewise, Vein Ablation Device,
Thermal Ablation Device, Injector Type actuator syringe, Transabdominal
(Fetoscope) Aminoscope and Accessories, Anastomosis Device for
Microvascular Surgery, Anastomosis Device for Gastroenterology Urology
Use, Anaesthetic Conduction Kit, Ophthalmic Laser and Accessories,
Embolic Particles System, Elbow joint humeral (hemi-elbow) metallic
uncemented prosthesis, Peritoneal Automatic Delivery System, Implanted
Subcutaneous Intravascular Port & Catheter, Elbow joint humeral
(hemi-elbow) metallic uncemented prosthesis, Pacemaker lead adaptor,
Surgical Dressings, etc have been listed in the moderate to high risk
Class C category.
Bolster Suture, Cyclodialysis eye Cannula,
Nasopharyngeal Catheter/Nasopharyngea l Class A, Umbilical occlusion
device, Incontinence Urosheath Device, Pharynscope, etc have been
included in the Class A category.
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